Deciphering New U.S. Laws Around Predetermined Change Control Plans

By Yu Zhao, Rene Hardee, Randy Horton, Ashley Miller, Michael Iglesias, Roma Williams, and Jaden Maloney

This is the second article in our three-part article series on postmarket change controls and implementing a Predetermined Change Control Plan (PCCP) for Class II Software as a Medical Device (SaMD) products beyond artificial intelligence/machine learning (AI/ML):

• Article 1: Medical Device Postmarket Change Controls & FDA 510(k) Software Modification Guidance
• Article 2 (this article): Deciphering New U.S. Laws Around Predetermined Change Control Plans
• Article 3: SaMD PCCP Implementation Beyond AI/ML: Considerations & Questions

Deciphering FDORA Section 3308 (PCCP)

Section 3308 of FDORA

As is typical with legislative language, the language used in Section 3308 of the Food and Drug Omnibus Reform Act (FDORA) can be difficult to understand, with multiple cross-references to existing laws and use of legal terminology that can be cryptic. Eventually, the FDA will clarify the new law by updating the existing code of federal regulations (CFR) and/or by issuing guidance documents.

In the meantime, we provide our initial interpretation of Section 3308 in the following table to assist medical device manufacturers in better understanding the new authority granted to the FDA regarding PCCP.

Section 3308 of the FDORA contains two subsections:

• The first subsection, 3308 (a), adds a new section to the Food, Drug and Cosmetic Act (FD&C Act) called Predetermined Change Control Plans for Devices, which is designated as Section 515C.
• The second subsection, 3308 (b), makes “conforming amendments” to the existing sections of the FD&C Act, which ensures the newly added Section 515C works in concert with other existing sections without creating any conflicts.

Sec. 3308: Predetermined Change Control Plans For Devices

Legislative Text:

(a) IN GENERAL. — Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515B (21 U.S.C. 360e–3) the following:

Interpretation: 3308(a) adds a new section to the FD&C Act called Predetermined Change Control Plans for Devices, designated as Section 515C.

Sec. 515C: Predetermined Change Control Plans For Devices

Legislative Text:

(a) APPROVED DEVICES. —

Interpretation: 515C(a) is for Class III PMA devices (or approved devices).

Note: Although the new law does not specifically reference humanitarian device exemption (HDE), it is important to note that HDE devices also can be approved under Section 515 of the FD&C Act as Class III devices. It is likely that the FDA may allow PCCPs to be submitted under an original HDE or a HDE supplement submission. For the purpose of this article, we will use the terms “PMA devices” and “PMA submissions” to include HDE devices and HDE submissions hereafter, respectively.

Legislative Text:

(1) IN GENERAL. — Notwithstanding section 515(d)(5)(A), a supplemental application shall not be required for a change to a device approved under section 515, if such change is consistent with a predetermined change control plan that is approved pursuant to paragraph (2).

Interpretation: 515C(a)(1): A PMA supplement is not required for a change made to a PMA device if such change is within the scope of and consistent with an authorized PCCP.

Legislative Text:

(2) PREDETERMINED CHANGE CONTROL PLAN. — The Secretary may approve a predetermined change control plan submitted in an application, including a supplemental application, under section 515 that describes planned changes that may be made to the device (and that would otherwise require a supplemental application under section 515), if the device remains safe and effective without any change.

Interpretation: 515C(a)(2): The FDA may approve a PCCP submitted under an original PMA or a PMA supplement for planned or anticipated future changes to a PMA device. Such future changes may otherwise require PMA or PMA supplement submissions without being pre-authorized under a PCCP.

We interpret that the conditional statement, “if the device remains safe and effective without any change,” under (a)(2) refers to future changes implemented under the authorized PCCP should not include changes that are intended to fix a baseline device that has significant safety or effectiveness issues. For example, even if a proposed change is within the scope of the authorized PCCP, if such change is made to fix significant safety and/or effectiveness issues existing in the baseline device, the FDA will likely require a submission (e.g., change being effected, or CBE, or a PMA supplement).

Legislative Text:

(3) SCOPE. — The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan.

Interpretation: 515C(a)(3): The FDA may require the PCCP to include certain elements, such as product labeling, to ensure continued safety and effective use of the modified device by the intended users, performance criteria for changes implemented under the PCCP, and a control plan, such as customer notification if an implemented change does not perform in the field as intended. Depending on the nature and degree of the performance issue, a correction or removal report to the FDA and/or a product recall may be necessary under certain circumstances.

Legislative Text:

(b) CLEARED DEVICES. —

Interpretation: 515C(b) is for non-exempt Class II 510(k) devices (i.e., cleared devices).

Note: “Cleared devices” include non-exempt Class II devices granted through de novo classification requests.

Legislative Text:

(1) IN GENERAL. — Notwithstanding section 510(k), a premarket notification shall not be required for a change to a device cleared under section 510(k), if such change is consistent with an established predetermined change control plan granted pursuant to paragraph (2).

Interpretation: 515C(b)(1): A new 510(k) is not required for a change made to a 510(k) device if such change is within the scope of and consistent with an approved PCCP.

Legislative Text:

(2) PREDETERMINED CHANGE CONTROL PLAN. — The Secretary may clear a predetermined change control plan submitted in a notification submitted under section 510(k) that describes planned changes that may be made to the device (and that would otherwise require a new notification), if—

‘‘(A) the device remains safe and effective without any such change; and

‘‘(B) the device would remain substantially equivalent to the predicate.

Interpretation: 515C(b) (2): The FDA may approve a PCCP submitted under a 510(k) or a de novo request for planned or anticipated future changes to a non-exempt Class II 510(k) device. Such future changes may otherwise require new 510(k) submissions without being pre-cleared under a PCCP.

• We expect that a PCCP can be submitted in a de novo classification request for a new non-exempt Class II regulation. Once the de novo request is granted, such device becomes a non-exempt Class II 510(k) device.
• We interpret that the two conditional statements, “if (A) the device remains safe and effective without any such change; and (B) the device would remain substantially equivalent to the predicate,” under (b)(2) refer to future changes implemented under the authorized PCCP should not include changes that either (A) are intended to fix a baseline device that has significant safety or effectiveness issues, or (B) make the modified devices no longer substantially equivalent to the last cleared devices. These are the exceptions to implementing changes per PCCP without a new 510(k) submission.
• If a change is made to fix significant safety and/or effectiveness issues existing in the baseline device, the FDA will likely require a submission (e.g., a CBE 510(k) or a 510(k)) for such a change that is otherwise consistent with the PCCP. If the modified device with a proposed future change will no longer be substantially equivalent to the last cleared device (i.e., the predicate device), the FDA will likely require a submission – a de novo or a 510(k) – for such change.

Legislative Text:

(3) SCOPE. — The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan.

Interpretation: 515C(b)(3): The FDA may require the PCCP to include certain elements, such as product labeling, to ensure continued safety and effective use of the modified device by the intended users, performance criteria for changes implemented under the PCCP, and a control plan, such as customer notification, if an implemented change does not perform in the field as intended. Depending on the nature and degree of the performance issue, a correction or removal report to the FDA and/or a product recall may be necessary under certain circumstances.

Legislative Text:

(c) PREDICATE DEVICES. — In making a determination of substantial equivalence pursuant to section 513(i), the Secretary shall not compare a device to changed versions of a device implemented in accordance with an established predetermined change control plan as a predicate device. Only the version of the device cleared or approved, prior to changes made under the predetermined change control plan, may be used by a sponsor as a predicate device.

Interpretation: 515C(c): Changed versions of a 510(k) device implemented under an authorized PCCP should not be used as the predicate device for future 510(k) premarket notifications. All future 510(k)s submitted by the same manufacturer for any change that (1) is not consistent with the PCCP and therefore not pre-authorized, AND (2) would trigger a new 510(k) submission, or 510(k)s submitted by different manufacturers, should use a predicate device, either a device version cleared by the FDA through a 510(k) premarket notification or granted through a de novo classification request.

Legislative Text:

(b) CONFORMING AMENDMENTS. —

Interpretation: FDORA Section 3308 (b) makes conforming amendments to the existing sections of the FD&C Act, which ensures the newly added Section 515C works in concert with other existing sections without creating any conflicts.

Legislative Text:

(1) CLEARED DEVICES. — Section 510(l)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)(1)) is amended, in the first sentence, by inserting ‘‘, or with respect to a change that is consistent with a predetermined change control plan cleared under section 515C’’ before the period at the end.

Interpretation: 3308(b)(1): Adding “or with respect to a change that is consistent with a predetermined change control plan cleared under section 515C” to 21 U.S.C. 360(l)(1) (or FD&C Act, Section 510(l)(1)) for non-exempt Class II 510(k) devices.

With the edits shown in the following paragraph, with underlines for new text, the amended 21 U.S.C. 360(l)(1) now reads as follows (Note: “Report under subsection (k)” refers to 21 U.S.C. 360(k) or FD&C Act 510(k) premarket notification requirement):

   §360. Registration of producers of drugs or devices

   (l) Exemption from reporting requirements

(1) A report under subsection (k) of this section is not required for a device intended for human use that is exempted from the requirements of this subsection under subsection (m) of this section or is within a type that has been classified into class I under section 360c of this title, or with respect to a change that is consistent with a predetermined change control plan cleared under section 515C. The exception established in the preceding sentence does not apply to any class I device that is intended for a use which is of substantial importance in preventing impairment of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.

Legislative Text:

(2) APPROVED DEVICES. — Section 515(d)(5)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(i)) is amended by striking ‘‘A supplemental’’ and inserting ‘‘Unless the change is consistent with a predetermined change control plan approved under section 515C, a supplemental.”

Interpretation: 3308(b)(2): Removing ‘‘A supplemental’’ and adding ‘‘Unless the change is consistent with a predetermined change control plan approved under section 515C, a supplemental’’ to 21 U.S.C. 360e(d)(5)(A)(i) (or Federal FD&C Act, Section 515(d)(5)(A)(i)) for Class III PMA devices.

With the edits shown in the following paragraph with strikethroughs for removed texts and underlines for new texts, the amended 21 U.S.C 360e(d)(5)(A)(i) now reads as follows:

§360e. Premarket approval

(d) Action on application for premarket approval

(5)(A)(i) A supplemental Unless the change is consistent with a predetermined change control plan approved under section 515C, a supplemental application shall be required for any change to a device subject to an approved application under this subsection that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing, and the holder of the approved application submits a written notice to the Secretary that describes in detail the change, summarizes the data or information supporting the change, and informs the Secretary that the change has been made under the requirements of section 360j(f) of this title.

Legislative Text:

(3) DOCUMENTATION OF RATIONALE FOR SIGNIFICANT DECISIONS. — Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is amended to read as follows:

‘‘(1) IN GENERAL.—The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 510(k), a petition for classification under section 513(f), an application under section 515, or an application for an exemption under section 520(g), including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.’’

Interpretation: 3308(b)(3): Amending Section 517A(a)(1) of the Federal FD&C Act.

With the edits shown in the following paragraph with strikethroughs for removed texts and underlines for new texts, the amended FD&C Act, Chapter V, Section 517A(a)(1) now reads as follows (Note: Section 517A pertains to requests for appeals of “significant decisions” concerning submissions under sections 510(k) (premarket notification), 513(f) (de novo classification request or de novo), 515 (Premarket Approval or PMA/Humanitarian Device Exemption or HDE), or 520(g) (Investigational Device Exemption or IDE) of the FD&C Act. Although the edits here are not directly related to the PCCP, since a PCCP can be submitted under a 510(k), a de novo, or a PMA or PMA supplement, and possibly under a HDE or HDE supplement, a manufacturer’s request for appeals of FDA’s decisions on these submissions could indirectly relate to the PCCPs submitted under such submissions.)

§517A AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS REGARDING DEVICES

(a) DOCUMENTATION OF RATIONALE FOR SIGNIFICANT DECISIONS.

(1) IN GENERAL.—The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 510(k), a petition for classification under section 513(f), an application under section 515, a request for designation under section 515B2, or an application for an exemption under section 520(g), including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.

What Has Changed And What Hasn’t

What has changed with the new statutory requirements under Section 3308 Predetermined Change Plans for Devices of the FDORA:

• The FDA now has clear statutory authority to exempt certain future changes to 510(k) devices and PMA devices from premarket notifications and premarket approval submissions, respectively, if such changes are consistent with the PCCP authorized by the FDA in a previous 510(k) (or de novo) or PMA submission.

What has not changed with the implementation of the PCCP under Section 3308:

• The premarket clearance and the premarket approval process, as well as their requirements, remain the same for all submissions (i.e., 510(k), de novo, and PMA).
  • The requirements for non-exempted 510(k) devices continue to be substantially equivalent to the last cleared predicate device with the implicit requirements for safety and effectiveness.
  • The requirements for PMA devices continue to be reasonable assurance of safety and effectiveness.

• For any premarket notification 510(k) submission, the eligible predicate device requirement remains the same, i.e., needs to be a device version that is cleared through the 510(k) process or granted through the de novo classification process.

Note: The new section 515C(c) clarifies that any device version implemented according to a PCCP cannot be used as a predicate device for any future 510(k) submission.

PCCP Frequently Asked Questions

What is an appropriate level of abstraction for the proposed changes included in the PCCP?

There has been significant debate around whether the proposed changes in the PCCP should be specific individual future changes or specific types of future changes. Describing a planned individual software change in detail can be a challenging task, and the actual change implemented will likely deviate from the plan to some extent. Therefore, it might be more effective to include specific types of changes in the PCCP, rather than specific individual changes. For example, “software modifications to update dashboard layout without content change and/or to adjust the number of images that can be viewed simultaneously on the dashboard for better user experience” would be a type of change, whereas as “software modification to increase the number of simultaneously displayed images from two to five, and to move displayed images to lower-right corner on the dashboard” would be a specific individual change.

This approach would allow for more flexibility in the decision-making process for manufacturers, while still maintaining the robustness of the PCCP change control process. By describing specific types of future changes and the decision-making process, the PCCP can accommodate changes that may not have been anticipated during the planning phase but for which the manufacturers have sufficient oversight to demonstrate that the FDA could entrust them with the discretion offered to them by a PCCP.

Does the PCCP cover non-exempt Class II and Class III device constituents of combination products?

This question is currently pending clarification from the FDA. It is possible that the general principles and required process for the PCCP may apply to software device constituent parts of combination products. It is important to note that combination products are subject to complex regulatory requirements, and that PCCPs may need to be adapted to address the specific needs and risks of each product.

Are there qualification requirements for the baseline device when requesting the PCCP? For example, can we submit a PCCP for a 510(k) device cleared more than 20 years ago?

Section 3308 of the FDORA does not specify any qualification requirements for the baseline device when requesting the PCCP. However, as a part of the PCCP review process, keep in mind that the FDA may research and use the baseline device’s regulatory and compliance history as one of the factors in its decision-making.

Article one of our three-part article series on postmarket change controls and implementing a Predetermined Change Control Plan (PCCP) for Class II SaMD products beyond artificial intelligence/machine learning (AI/ML) covered Medical Device Postmarket Change Controls & FDA 510(k) Software Modification Guidance. The third article will address SaMD PCCP implementation beyond AI/ML: considerations and challenges.

About The Lead Author:

Yu Zhao founded Bridging Consulting LLC, a consultancy dedicated to assisting AI startups and medical device companies in achieving innovation and regulatory compliance, in 2020. He has more than two decades of experience in the life sciences and technology space, and specializes in medical device regulatory, quality, and clinical affairs. His clients range from startups to large industry companies. During his tenure at Medtronic, he led regulatory affairs departments for multi-billion-dollar business units.

Contributing authors are Rene Hardee, director of regulatory and program management at MedSec; Randy Horton, chief solutions officer at Orthogonal; Ashley Miller, director of regulatory affairs at Digital Diagnostics; Michael Iglesias, global quality advisor at Roche; Roma Williams, student at the University of Miami; and Jaden Maloney, student at Johns Hopkins University’s Whiting School of Engineering.